Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 3:23 PM
Study NCT ID:
NCT01512108
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2012-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'Novo Nordisk maintains the right to be informed of any Investigator plans for publication and review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Novo Nordisk reserves the right to prior review of such publications and ask for delay of publication of individual site results until after the primary manuscript is accepted for publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were captured from the time of consent until 52 weeks of treatment and if needed were followed up after the final visit.', 'description': 'Safety analysis set included all subjects who received at least one dose of the trial product.', 'eventGroups': [{'id': 'EG000', 'title': 'Liraglutide 0.9 mg/Day', 'description': 'Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.', 'otherNumAtRisk': 240, 'otherNumAffected': 161, 'seriousNumAtRisk': 240, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Additional OAD', 'description': "Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling.", 'otherNumAtRisk': 120, 'otherNumAffected': 77, 'seriousNumAtRisk': 120, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 48, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 135, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 85, 'numAffected': 47}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Meningitis herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastric cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Large intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lung carcinoma unspecified stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Prostate cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Limb operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Treatment Emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 0.9 mg/Day', 'description': 'Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.'}, {'id': 'OG001', 'title': 'Additional OAD', 'description': "Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling."}], 'classes': [{'title': 'All AEs', 'categories': [{'measurements': [{'value': '361', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}]}, {'title': 'Mild AEs', 'categories': [{'measurements': [{'value': '345', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}]}, {'title': 'Moderate AEs', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Severe AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 52 + 7 days', 'description': "Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.", 'unitOfMeasure': 'Events/100 years of patient exposure', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all subjects who received at least one dose of the trial product.'}, {'type': 'SECONDARY', 'title': 'Number of Confirmed Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 0.9 mg/Day', 'description': 'Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.'}, {'id': 'OG001', 'title': 'Additional OAD', 'description': "Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling."}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 52', 'description': 'Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes \\[An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose \\<3.1 mmol/L (56 mg/dL) or full blood glucose \\<2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value \\<3.1 mmol/L (56 mg/dL) or full blood glucose value \\<2.8 mmol/L (50 mg/dL)\\] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL).', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set includes all subjects who received at least one dose of the trial product.'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c From Baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 0.9 mg/Day', 'description': 'Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.'}, {'id': 'OG001', 'title': 'Additional OAD', 'description': "Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.21', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated treatment difference, Mean', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '-0.09', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 52', 'description': 'Estimated mean change in HbA1c from baseline after 52 Weeks of treatment', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products and missing data were imputed using last observation carried forward (LOCF). One subject did not contribute to the statistical analysis at Week 52.'}, {'type': 'SECONDARY', 'title': 'Change in FPG From Baseline to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 0.9 mg/Day', 'description': 'Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.'}, {'id': 'OG001', 'title': 'Additional OAD', 'description': "Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.55', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0458', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated treatment difference, Mean', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '-0.01', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 52', 'description': 'Estimated mean change from baseline in FPG after 52 Weeks of treatment', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products and missing data were imputed using last observation carried forward (LOCF). One subject did not contribute to the statistical analysis at Week 52.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liraglutide 0.9 mg/Day', 'description': 'Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.'}, {'id': 'FG001', 'title': 'Additional OAD', 'description': "Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '243'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'Exposed', 'achievements': [{'comment': '3 subjects withdrew prior to exposure to trial drug', 'groupId': 'FG000', 'numSubjects': '240'}, {'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The trial was conducted at 36 sites in Japan.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liraglutide 0.9 mg/Day', 'description': 'Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.'}, {'id': 'BG001', 'title': 'Additional OAD', 'description': "Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '59.2', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glycosylated haemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '8.1', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '8.1', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '8.68', 'spread': '1.61', 'groupId': 'BG000'}, {'value': '8.96', 'spread': '1.82', 'groupId': 'BG001'}, {'value': '8.77', 'spread': '1.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 363}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2013-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-08', 'studyFirstSubmitDate': '2012-01-10', 'resultsFirstSubmitDate': '2014-04-25', 'studyFirstSubmitQcDate': '2012-01-13', 'lastUpdatePostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-25', 'studyFirstPostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment Emergent Adverse Events (AEs)', 'timeFrame': 'Week 0 to Week 52 + 7 days', 'description': "Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly."}], 'secondaryOutcomes': [{'measure': 'Number of Confirmed Hypoglycaemic Episodes', 'timeFrame': 'Week 0 to Week 52', 'description': 'Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes \\[An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose \\<3.1 mmol/L (56 mg/dL) or full blood glucose \\<2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value \\<3.1 mmol/L (56 mg/dL) or full blood glucose value \\<2.8 mmol/L (50 mg/dL)\\] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL).'}, {'measure': 'Change in HbA1c From Baseline to Week 52', 'timeFrame': 'Week 0, week 52', 'description': 'Estimated mean change in HbA1c from baseline after 52 Weeks of treatment'}, {'measure': 'Change in FPG From Baseline to Week 52', 'timeFrame': 'Week 0, week 52', 'description': 'Estimated mean change from baseline in FPG after 52 Weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '26816604', 'type': 'RESULT', 'citation': 'Kaku K, Kiyosue A, Ono Y, Shiraiwa T, Kaneko S, Nishijima K, Bosch-Traberg H, Seino Y. Liraglutide is effective and well tolerated in combination with an oral antidiabetic drug in Japanese patients with type 2 diabetes: A randomized, 52-week, open-label, parallel-group trial. J Diabetes Investig. 2016 Jan;7(1):76-84. doi: 10.1111/jdi.12367. Epub 2015 Jul 14.'}, {'pmid': '28984041', 'type': 'RESULT', 'citation': 'Kiyosue A, Seino Y, Nishijima K, Bosch-Traberg H, Kaku K. Safety and efficacy of the combination of the glucagon-like peptide-1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post-hoc analysis of a randomized, 52-week, open-label, parallel-group trial. J Diabetes Investig. 2018 Jul;9(4):831-839. doi: 10.1111/jdi.12759. Epub 2017 Nov 24.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.)\n* Japanese subjects with type 2 diabetes on monotherapy with an OAD (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved Japanese labelling in addition to diet and exercise therapy. Total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to Visit 1\n* Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months\n* HbA1c between 7.0-10.0% (both inclusive)\n* Body Mass Index (BMI) below 40.0 kg/m\\^2\n* Outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. However, hospitalisation for training of self-injection from Visit 2 that is for no longer than one week is allowed\n* Subjects able and willing to perform self-monitoring of plasma glucose (SMPG)\n\nExclusion Criteria:\n\n* Subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)\n* Calcitonin above or equal to 160 pg/mL\n* Personal history of non-familial medullary thyroid carcinoma\n* Family or personal history of multiple endocrine neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (FMTC)\n* History of chronic pancreatitis or idiopathic acute pancreatitis\n* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months\n* Treatment with GLP-1 receptor agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor within 12 weeks prior to Visit 1\n* Having contraindications to liraglutide and any of the OADs (according to Japanese labelling)'}, 'identificationModule': {'nctId': 'NCT01512108', 'briefTitle': 'Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A 52-week, Multi-centre, Open-labelled, Randomised (2:1), Parallel-group Trial With an Active Control (Two OADs Combination Therapy) to Evaluate the Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Monotherapy', 'orgStudyIdInfo': {'id': 'NN2211-3924'}, 'secondaryIdInfos': [{'id': 'U1111-1121-3457', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'JapicCTI-121744', 'type': 'REGISTRY', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liraglutide + an OAD therapy', 'interventionNames': ['Drug: liraglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Two OADs combination therapy', 'interventionNames': ['Drug: oral anti-diabetic drug']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': '0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).', 'armGroupLabels': ['Liraglutide + an OAD therapy']}, {'name': 'oral anti-diabetic drug', 'type': 'DRUG', 'description': 'An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose.', 'armGroupLabels': ['Two OADs combination therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '103 0002', 'city': 'Chuo-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '103 0027', 'city': 'Chuo-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '790 0067', 'city': 'Ehime, Japan', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '812 0025', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '818 8502', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '820 8505', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.6, 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